Phase II Study of Temsirolimus (CCI-779), a Novel Inhibitor of mTOR, in Heavily Pretreated Patients With Locally Advanced or Metastatic Breast Cancer
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- Stephen Chan
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Max E. Scheulen
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Stephen Johnston
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Klaus Mross
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Fatima Cardoso
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Christian Dittrich
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Wolfgang Eiermann
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Dagmar Hess
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Rudolph Morant
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Vladimir Semiglazov
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Markus Borner
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Marc Salzberg
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Valerijus Ostapenko
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Hans-Joachim Illiger
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Dirk Behringer
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Nathalie Bardy-Bouxin
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Joseph Boni
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Steven Kong
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Maria Cincotta
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
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- Laurence Moore
- From the Nottingham City Hospital, Nottingham; Royal Marsden Hospital, London, United Kingdom; Innere Klinik und Poliklinik (Tumorforschung), Universitätsklinikum Essen, Essen; Frauenklinik Rotes Kreuz, Munich; Klinik für Tumorbiologie, Freiburg; Stadtische Kliniken Oldenburg, Oldenburg; Albert Ludwigs-Universität Freiburg, Freiburg, Germany; Institut Jules Bordet, Brussels, Belgium; Ludwig Boltzmann-Institute for Applied Cancer Research, Kaiser-Franz-Josef-Spital, Vienna, Austria; Kantonsspital St....
抄録
<jats:sec><jats:title>Purpose</jats:title><jats:p> In this study, two doses of temsirolimus (CCI-779), a novel inhibitor of the mammalian target of rapamycin, were evaluated for efficacy, safety, and pharmacokinetics in patients with locally advanced or metastatic breast cancer who had been heavily pretreated. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients (n = 109) were randomly assigned to receive 75 or 250 mg of temsirolimus weekly as a 30-minute intravenous infusion. Patients were evaluated for tumor response, time to tumor progression, adverse events, and pharmacokinetics of temsirolimus. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Temsirolimus produced an objective response rate of 9.2% (10 partial responses) in the intent-to-treat population. Median time to tumor progression was 12.0 weeks. Efficacy was similar for both dose levels but toxicity was more common with the higher dose level, especially grade 3 or 4 depression (10% of patients at the 250-mg dose level, 0% at the 75-mg dose level). The most common temsirolimus-related adverse events of all grades were mucositis (70%), maculopapular rash (51%), and nausea (43%). The most common, clinically important grade 3 or 4 adverse events were mucositis (9%), leukopenia (7%), hyperglycemia (7%), somnolence (6%), thrombocytopenia (5%), and depression (5%). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> In heavily pretreated patients with locally advanced or metastatic breast cancer, 75 and 250 mg temsirolimus showed antitumor activity and 75 mg temsirolimus showed a generally tolerable safety profile. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 23 (23), 5314-5322, 2005-08-10
American Society of Clinical Oncology (ASCO)
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詳細情報 詳細情報について
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- CRID
- 1363951795471939456
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- NII論文ID
- 30022792250
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- ISSN
- 15277755
- 0732183X
- http://id.crossref.org/issn/0732183X
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- データソース種別
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- Crossref
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